Kornimate/medical-research-clean huggingface dataset:
the solace-au clinical trial

Conditions: Severe, Symptomatic Aortic Stenosis

Summary: the objective of the study is to observe the safety, efficacy and cost effectiveness of the edwards sapien xt valve for the treatment of severe calcific degenerative aortic stenosis.

this is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. the comparatator group will consist of subjects undergoing surgical aortic valve replacement in cohort a of the partner ii trial \[nct01314313\].

Eligibility criteria:
inclusion criteria: * age \> 70 years * sts score \> 4 * heart team agrees on eligibility including assessment that tavr or avr is appropriate exclusion criteria: * age \<70 years * evidence of an acute myocardial infarction ≤ 30 days * aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified * stroke or transient ischemic attack (tia) within 6 months of the procedure

Keywords: aortic stenosis transfemoral transcatheter heart valve
reducing post-tonsillectomy pain by tonsil pillars suturing.

Conditions: Post - Tonsillectomy Pain

Summary: comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.


Eligibility criteria:
inclusion criteria: 1. aged 18 and over. 2. patients with tonsillectomy indication due to chronic tonsillitis. exclusion criteria: 1. patients with tonsillectomy indication without chronic tonsillitis ( due to other causes). 2. chronic disease, chronic neurology disease. 3. chronic psychology disease. 4. bleeding tendency.
changes in inhibition and valuation after eating

Conditions: Bulimia Nervosa

Summary: an impaired ability to exert control has been implicated in bulimia nervosa (bn), but this impairment may not represent a stable trait or be the most effective focus for treatment. this project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with bn, thereby maintaining cycles of binge eating, purging, and restriction.

the overarching goal of this project is to test a neurocomputational model of bn that incorporates learning and decision-making components of control. the study combines functional magnetic resonance imaging (fmri), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in bn. more specifically, the study has the following main objectives: 1) to determine the influence of eating on control-related prediction updating in bn.; 2) to determine the influence of eating on control-related cognitive effort valuation in bn; 3) to use state-specific neural activation to predict bn symptoms.

Eligibility criteria:
inclusion criteria: * female * aged 18 to 45 years * current bmi greater than or equal to 18.5kg/m2 but under 30kg/m2 * right-handed * english-speaking additional inclusion criteria for women with bulimia nervosa: * meet dsm-5 criteria for bulimia nervosa exclusion criteria: * medical instability * ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation * shift work * pregnancy, planned pregnancy, or lactation during the study period * allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period * any contraindication for fmri
high intensity phototherapy: double vs. single

Conditions: Hyperbilirubinemia

Summary: intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. it has been debated if there is an upper limit on the efficiency of phototherapy. this study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using light emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.

hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among others because of immaturity of the enzyme uridin-glukuronosyl-transferase (ugt1a1) in the liver. in seldom cases with very high total serum bilirubin concentration (tsb), bilirubin can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central nervous system may cause acute bilirubin encephalopathy (abe). this can progress to chronic bilirubin encephalopathy (cbe), a devastating condition, which unfortunately still occurs, even in industrialised countries. hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which means, they need treatment to prevent abe and the treatment of choice is phototherapy due to its efficacy and safety. hereby bilirubin in the skin and plasma is converted to photobilirubins; they are water-soluble and can be excreted through the liver without conjugation. they are presumably non-toxic. in most departments, single phototherapy is first choice. to avoid the above-mentioned damaging condition, it is very important to optimize phototherapy. former fluorescent tubes were used as light source, but now light emission diodes (led) are used. this study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using led, and whether there is an upper limit for the efficacy of phototherapy. it is a prospective, randomised controlled study. the infants will be randomized to either 1: conventional phototherapy with blue led light from above and a distance from light source to mattress of 30 cm, giving a light irradiance of 66 µw/cm2/nm or 2: conventional phototherapy combined with a light blanket (bilisoft) with a light irradiance by the skin of 39 µw/cm2/nm. tsb will be measured at start and after 12 - and 24 h of treatment. based on the calculation of strength 72 infants will be needed in this study. as statistical methods t-tests will be used and multiple linear regression models will be used to adjust for confounding.

Eligibility criteria:
inclusion criteria: * otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease * gestational age ≥33 weeks * birth weight ≥1800 g * the infants should be treatable in a cradle exclusion criteria: * infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing tsb will not be enrolled.
a phase i pharmacokinetic study in hiv-positive subjects of oral ganciclovir and concomitant antiretroviral zidovudine and didanosine

Conditions: Cytomegalovirus Infections; HIV Infections

Summary: to determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (azt) and between oral ganciclovir and oral didanosine (ddi). to determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. to obtain data on the short-term safety of oral ganciclovir administered concurrently with azt, ddi, or probenecid in hiv-positive patients.

patients currently on either azt or ddi receive ganciclovir therapy.

Eligibility criteria:
inclusion criteria concurrent medication: required: * concomitant azt or ddi. allowed: * probenecid. * aerosolized pentamidine. patients must have: * asymptomatic hiv infection. * cmv seropositivity or cmv culture positivity at present or at any time in the past. * no history of cmv disease (e.g., retinitis, colitis) or any other aids-defining illness. * treatment with azt or ddi for at least 1 month prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * uncontrolled diarrhea (three or more loose stools/day). * clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. * azt patients only: * deficiency in glucose-6-phosphate dehydrogenase. * ddi patients only: * grade 2 or worse peripheral neuropathy. concurrent medication: excluded: * combination antiretroviral therapy. * g-csf or gm-csf. * acyclovir. * amphotericin b. * amikacin. * captopril. * carbamazepine. * cimetidine. * cyclosporine. * glutethimide. * gentamicin. * griseofulvin. * ibuprofen. * imipenem-cilastatin. * lithium. * methicillin. * methotrexate. * naproxen. * pentamidine (pentam 300) (aerosolized drug permitted). * phenacetin. * phenobarbital. * phenytoin. * piroxicam. * ribavirin. * rifampin. * tobramycin. * vidarabine. * zalcitabine. * other investigational drugs. patients with the following prior conditions are excluded: * history of hypersensitivity to acyclovir or ganciclovir. * azt patients only: * history of gout, uric acid, kidney stones, peptic ulcer or porphyria. * ddi patients only: * history of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy. prior medication: excluded: * combination antiretroviral therapy within 1 month prior to study entry. required: * azt at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). or * ddi at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry). history of alcoholism (in ddi patients).

Keywords: didanosine ganciclovir drug interactions cytomegalovirus infections acquired immunodeficiency syndrome zidovudine
stopping ace-inhibitors in covid-19

Conditions: SARS-CoV-2; COVID-19

Summary: acei-covid-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ace-inhibitors (acei) or angiotensin receptor blockers (arb) improves outcomes in symptomatic sars-cov2-infected patients

the covid-19 pandemic currently poses unprecedented challenges to the health systems of all countries. experimental studies show that the sars-cov2 virus enters human cells via the angiotensin converting enzyme ii receptor 2 (ace2). ace inhibitors (acei) and angiotensin receptor blockers (arb) can lead to an increase in the expression of ace2. therefore, there is concern that in patients treated with acei or arb, the absorption of the virus is facilitated, thereby accelerating its spread in the body. acei-covid tests the hypothesis that stopping chronic acei / arb therapy in sars-cov2-infected patients improves outcomes.

Eligibility criteria:
inclusion criteria: * female and male patients competent to make a decision * proven and symptomatic sars-cov2 infection ≤ 5 days * patient age ≥ 18 years * provided written informed consent * chronic (≥ 1 month) acei/arb therapy for treatment of arterial hypertension, diabetes mellitus, heart failure or coronary artery disease * stable hemodynamic conditions allowing to stop or continue treatment with acei/arb (systolic blood pressure ≤180mmhg) exclusion criteria: * women capable of bearing children as well as pregnant and breastfeeding women * participant in another interventional trail * at screening visit, no oral medication intake possible * advanced heart failure nyha stage iii-iv * left ventricular ejection fraction \<30% or ntprobnp ≥600pg/ml in case of clinical signs of heart failure * acute coronary syndrome ≤ 3 months * severe arterial hypertension (concomitant use of more than 4 different antihypertensive drug classes) * acute respiratory distress syndrome with need for mechanical ventilation * patients who at not capable of home blood pressure monitoring * patients who cannot be switched to an alternative medication

Keywords: ace-inhibitors ras system angiotensin receptor blockers sars-cov-2 covid-19
nasal obstruction compared by rhinomanometry and nasal inspiratory peak flow after endoscopic nasal surgery

Conditions: Pituitary Adenoma Invasive; Nasal Obstruction

Summary: the aim of the project is to determine whether nasal inspiratory peak flow is sufficient for preoperative and postoperative measurement of nasal patency compared to rhinomanometry.

the nasal cavity is used to heat, humidify and purify the air before entering other parts of the respiratory system. other functions of the nose include in particular olfactory, immune, reflex, or sexual functions. proper airflow through the nasal cavity is essential for all nasal functions; anatomical or flow changes can significantly affect nasal functions. endoscopic transnasal surgical approaches are modern, mini-invasive methods, enabling the solution of pathologies in the area of the cranial base, through the nasal cavity. the advantage of this technique is the absence of external incisions and scars and significantly better cosmetic effect, these methods also offer very good clarity and illumination of the operating field. the main disadvantage is the risk of affecting the functions of the nose. to create a transnasal approach to the skull base, it is necessary to perform lateralization of middle turbinates, resection of the anterior wall of the sphenoidal sinus, and resection of the posterior part of the nasal septum. these interventions are necessary for a good overview and manipulation in the operated area, however, they can lead to postoperative changes in the physiological functions of the nasal cavity, especially loss of smell, and taste, altered airflow through the nasal cavity, mucociliary transport disorders, nasal obstruction, crusting or drying mucous membrane. all these adverse changes significantly affect the patient's quality of life. as a standard, rhinomanometry is used to measure nasal patency before and after surgery. a modern new method is measuring the patency of the nasal cavity using an npif (nasal peak inspiratory flow) device, which has significantly lower acquisition costs, is easy to use, and, above all, fast. the disadvantage is that the examination is less detailed, the result is the amount of air flowing in l/min through the nasal cavity.

Eligibility criteria:
inclusion criteria: * age over 18 years * patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma exclusion criteria: * patients after surgery of the nasal cavity or base of the skull * patients with nasal disease and paranasal sinuses * patients with olfactory disorders before surgery * patients with nasal septal deviation that requires septoplasty

Keywords: pituitary adenoma nasal surgery rhinomanometry nasal inspiratory peak flow endoscopic nasal surgery
recovery prediction of motor function using neuroimaging techniques in subacute stroke patients

Conditions: Stroke

Summary: prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. to achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.


Eligibility criteria:
inclusion criteria: * first-ever stroke patients * unilateral stroke * subacute stage (less than 4 weeks) exclusion criteria: * major active neurological disease or psychiatric disease * a history of seizure * metallic implants in their brain

Keywords: brain connectivity magnetic resonance imaging recovery prediction
effects of social gaze training on brain and behavior in fragile x syndrome

Conditions: Fragile X Syndrome; Intellectual Disability

Summary: the purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile x syndrome (fxs). the investigators will use the principles of applied behavior analysis (aba) to shape appropriate social skills. importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.


Eligibility criteria:
inclusion criteria: 1. boys diagnosed with fragile x syndrome 2. boys with intellectual disability who do not have fxs or other known genetic disorder associated with intellectual disability 3. age 8 to 18 years inclusive 4. ability to travel to stanford 5. vineland adaptive behavior scales standard score between 50 and 75 points exclusion criteria: 1. sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease). 2. materials in body that would preclude an mri scan (e.g., dental braces).
chronic pelvic pain in women - conservative group treatment compared to standard conservative treatment.

Conditions: Pelvis Pain Chronic

Summary: the purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (cpp). the hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with cpp. the participants will be randomized to one of two treatment arms, and the treatment effect will be evaluated 12 months after start of intervention.

background: chronic pelvic pain (cpp) is a common source of pain and reduced quality of life among women throughout the world. cpp is a complex condition, and the understanding of both etiology and effective treatment is limited. the newest/latest clinical guidelines recommend a holistic and multidisciplinary treatment approach to this condition. in accordance with the guidelines a multidisciplinary group based treatment for women with cpp has been started at the university hospital of north norway. the treatment is offered to patients who are considered to benefit from conservative treatment approach. method: to investigate the effect of a group based treatment compared to standard conservative treatment by physiotherapists in primary or secondary health care, a randomized controlled trial will be conducted. patients who are found eligible and consent to participate in the trial, will be randomized to one of the two treatment options. data will be registered at baseline, 3, 6 and 12 months after start of treatment.

Eligibility criteria:
inclusion criteria: * chronic pelvic pain lasting minimum 6 months * motivated for group intervention exclusion criteria: * pelvic pathology that needs medical treatment other than conservative * pregnancy, or labour last 12 months. * abdominal or pelvic surgery the last 6 months * botox injections in pelvic areas last 4 months. * drug addiction or using large dozes of analgesics * serious psychiatric diagnosis. consent capability is necessary. * not speaking/writing norwegian language * previously treated by physiotherapist involved in the group intervention in this project
care management for patients with alzheimer disease and their family caregivers

Conditions: Alzheimer's Disease; Dementia

Summary: this is a clinical trial to test the effectiveness of current guideline for the care of older adults with alzheimer's disease. the study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. we are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings

the specific aim of this proposal is to conduct a four-year randomized controlled clinical trial to test the efficacy of an integrated program of collaborative care as compared to usual care in improving the process and outcomes of care for older adults with dementia in a primary care setting. the program involves three primary components: (1) a comprehensive screening and diagnosis program in which all older adults aged 65 and older from wishard's community health centers will be screened for dementia. patients with evidence of dementia will receive further evaluation to determine an explicit diagnosis. roudebush va medical center patients aged 65 and older with a diagnosis of dementia will receive further evaluation to determine an explicit diagnosis. (2) a multidisciplinary team approach to care for patients with dementia. this care will be coordinated through a geriatric nurse practitioner or a clinical nurse specialist working in the primary care clinic. the team includes primary care and specialist physicians, psychologist, other health care workers, and relevant social service agencies working to adhere to recommended standards of care for primary care patients with dementia. (3) a proactive longitudinal tracking program in which objective measures of process and outcomes of care are fed back to the collaborative care team so that appropriate changes in the course of therapy can be undertaken. although authoritative guidelines for the care of patients with alzheimer disease and related disorders have been published, there are no clinical trials that test the impact of close adherence to these guidelines on the outcomes of care for a group of vulnerable older adults in an urban primary care setting. we are hypothesizing that patients with dementia and their caregivers who are exposed to this program will: (1) be more likely to receive the emerging standard of care for dementia, including an explicit diagnosis of dementia and an appropriate level of evaluation, education, and management; (2) be less impaired by psychopathology and behavior disturbances; (3) be less functionally impaired at 1-year and 2-year follow-up.

Eligibility criteria:
inclusion criteria: * alzheimers disease exclusion criteria: * inability to understand english * no telephone
circuit-based approach to suicide: biomarkers, predictors, and novel therapeutics

Conditions: Major Depressive Episode; Borderline Personality Disorder; Suicide

Summary: this neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (itbs-tms) to the inferior parietal lobule (ipl) in reducing suicide risk in patients with major depressive episode (mde) or borderline personality disorder (bpd).

this neuroimaging study aims to determine the effectiveness of itbs-tms to the ipl in reducing suicide risk in patients with mde or bpd. this study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to itbs-tms and its mechanism of action.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * diagnosed with bpd or mde * chief complaint of suicidal thoughts and behaviors exclusion criteria: * neurological conditions with known structural brain lesion * prior neurosurgical procedure * metal in the body that is ferromagnetic or metal injury to the eyes * epilepsy * implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, tens unit, or ventriculo-peritoneal shunt * psychopathology not appropriate for the treatment (e.g., manic episode or psychosis) * current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report * inability to meet the safety criteria for mri scanning according to the protocols of the mgh department of radiology * current pregnancy

Keywords: transcranial magnetic stimulation intermittent theta burst